BOTOX® Treatment in Pediatric Lower Limb Spasticity

Last updated: July 16, 2018
Sponsor: Allergan
Overall Status: Completed

Phase

3

Condition

Limb Spasticity

Cerebral Palsy

Treatment

N/A

Clinical Study ID

NCT01603628
191622-111
2012-000042-35
  • Ages 2-16
  • All Genders

Study Summary

This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with lower limb spasticity.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Minimum weight of 10 kg/22 lb

  • Cerebral palsy with dynamic muscle contracture /spasticity of the ankle

Exclusion

Exclusion Criteria:

  • Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateralsclerosis, or mitochondrial disease

  • Uncontrolled epilepsy

  • Botulinum Toxin therapy of any serotype for any condition within the last 6 months

  • History of surgical intervention of the lower study leg or planned surgery of any limbduring the study

  • Previous casting of the study limb for spasticity within 6 months or with a dynamicsplint within 3 months, or planned casting or dynamic splinting for spasticity of thestudy limb or affected upper limb during the study

Study Design

Total Participants: 384
Study Start date:
September 11, 2012
Estimated Completion Date:
June 28, 2017

Connect with a study center

  • Holland Bloorview Kids Rehab

    Toronto, M4G-1R8
    Canada

    Site Not Available

  • Semmelweis Egyetem- Ortopédiai Klinika

    Budapest, 1113
    Hungary

    Site Not Available

  • Debrecen University Clinical Center, Orthopedic Clinic

    Debrecen, 4032
    Hungary

    Site Not Available

  • empty

    Conegliano,
    Italy

    Site Not Available

  • Istituto IRCCS G. Gaslini

    Genoa, 16148
    Italy

    Site Not Available

  • Daegu Fatima Hospital

    Daegu, 41199
    Korea, Republic of

    Site Not Available

  • National Health Insurance Service Ilsan Hospital

    Gyeonggi-do, 10444
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752
    Korea, Republic of

    Site Not Available

  • De La Salle University Medical Center

    Cavite, 4114
    Philippines

    Site Not Available

  • Philippine Children's Medical Center

    Quezon City, 1104
    Philippines

    Site Not Available

  • Philippine Orthopedic Center

    Quezon City, 1100
    Philippines

    Site Not Available

  • St. Luke's Medical Center-Quezon City

    Quezon City, 1102
    Philippines

    Site Not Available

  • Uniwersytecki Dzieciecy Szpita

    Białystok, 15-274
    Poland

    Site Not Available

  • Centrum Rehabilitacji Krok po Kroku

    Gdansk, 80-389
    Poland

    Site Not Available

  • Uni Centrum Kliniczne

    Gdansk, 80-219
    Poland

    Site Not Available

  • Specjal. Gabinet Neurologiczny

    Krakow, 30-359
    Poland

    Site Not Available

  • Centrum Medyczne "POMOC"

    Lodz, 93-271
    Poland

    Site Not Available

  • CRH ŻAGIEL MED, Lublin

    Lublin, 20-601
    Poland

    Site Not Available

  • INTERMED, Lublin

    Lublin, 20-058
    Poland

    Site Not Available

  • Szpital Wojewódzki Nr 2

    Rzeszów, 35-301
    Poland

    Site Not Available

  • NZOZ Mazowieckie Centrum

    Warsaw, 05-462
    Poland

    Site Not Available

  • Neuro - Dzieci I Mlodziezy Aga

    Warsaw, 02-315
    Poland

    Site Not Available

  • empty

    Wiązowna,
    Poland

    Site Not Available

  • Childrens Republic Hospital

    Kazan, 420138
    Russian Federation

    Site Not Available

  • Smolensk Regional Hospital- Regional Budget State Healthcare institution

    Smolensk, 214018
    Russian Federation

    Site Not Available

  • Tyumen Regional Hospital #2 - State Budget Healthcare Institution of Tyumen region

    Tyumen, 625039
    Russian Federation

    Site Not Available

  • Siriraj Hospital, Mahidol University

    Bangkok, 10700
    Thailand

    Site Not Available

  • Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University

    Chiang Mai, 50200
    Thailand

    Site Not Available

  • Srinagarind Hospital, Khon Kaen University

    Khon Kaen, 40002
    Thailand

    Site Not Available

  • Ankara Diskapi Yildrim Beyazit

    Ankara, 6110
    Turkey

    Site Not Available

  • Kocaeli Üniversitesi

    Kocaeli, 41380
    Turkey

    Site Not Available

  • Selçuk Üniversitesi

    Konya, 42250
    Turkey

    Site Not Available

  • AMS Neurology

    Pasadena, California 91106
    United States

    Site Not Available

  • Harrison Clinical Management

    Pomona, California 91767
    United States

    Site Not Available

  • Rady Children's Hospital San Diego

    San Diego, California 92123
    United States

    Site Not Available

  • Children's Hospital Colorado Dept. of PM&R

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Associated Neurologists of Southern CT, P.C.

    Fairfield, Connecticut 06824
    United States

    Site Not Available

  • New England Center for Clinical Research

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • NW FL Clinical Research Group, LLC

    Gulf Breeze, Florida 32561
    United States

    Site Not Available

  • Axcess Medical Research, LLC

    Loxahatchee, Florida 33470
    United States

    Site Not Available

  • Axcess Medical Research, LLC

    Loxahatchee Groves, Florida 33470
    United States

    Site Not Available

  • Pediatric Neurology, PA

    Orlando, Florida 32819
    United States

    Site Not Available

  • Children's Healthcare of Atlanta Children's Rehabilitation Associates

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Rehab Institute of Chicago

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Beaumont Children's Hospital Pediatric Research

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • Gillette Children's Specialty Healthcare

    Saint Paul, Minnesota 55101
    United States

    Site Not Available

  • The Children's Mercy Hospital & Clinics

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Clinical Research Center of New Jersey

    Voorhees, New Jersey 08043
    United States

    Site Not Available

  • Columbia University Medical Center Dept. of Rehab. & Regenerative Medicine

    New York, New York 10032
    United States

    Site Not Available

  • NYU Hospital for Joint Diseases

    New York, New York 10003
    United States

    Site Not Available

  • OnSite Clinical Solutions, LLC

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • PMG Research of Charlotte, LLC

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75235
    United States

    Site Not Available

  • Baylor College of Medicine Texas Children's Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Road Runner Research

    San Antonio, Texas 78258
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

  • Marshfield Clinic

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

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